Glecaprevir/ Pibrentasvir may halt transmission of Acute Hepatitis C infection and help it's elimination

Hepatitis C is a life causing liver infection caused by the hepatitis C virus (HCV). Hepatitis C is spread through contact with blood from an infected person. Most people reportedly get infected by the hepatitis C virus by sharing needles or other equipment used to prepare and inject drugs.

According to a new study presented at The Liver Meeting 2023 from the American Association for the Study of Liver Diseases, an 8-week course of glecaprevir/pibrentasvir (G/P) treatment was a safe and effective treatment for adults and adolescents with previously untreated acute hepatitis C virus infection, Therapy demonstrated a virologic response at post treatment week 12 (SVR12) rate, which was superior to the prior efficacy threshold.

Researchers conducted a retrospective, noninterventional, single-arm patient chart review study evaluated the efficacy and safety of an 8-week G/P intervention in patients with acute HCV infection across 7 countries. Data was obtained 6 months prior to the first G/P dose though 24 weeks posttreatment. Eligible patients had an acute HCV infection, were aged ≥12 years, had no history of liver or kidney transplant or liver decompensation, and were naïve to HCV treatment for their current infection.

The primary efficacy endpoint was SVR12 in the modified full analysis set (mFAS), excluding nonvirologic failures, which was compared to an efficacy threshold, defined as 92.6% by previous G/P SVR12 rates from chronic HCV trials. Other efficacy endpoints included on-treatment virologic failure (OTVF), and relapse and reinfection in the FAS. Safety endpoints were adverse events (AEs) and alanine aminotransferase (ALT). Efficacy was assessed using HCV ribonucleic acid (RNA) data.

The key points of the study are

• a total, 202 patients were included in the FAS assessment, of which most (85.1%) were male, 88.6% were White, 98.6% were noncirrhotic, 68.5% did not have a prior HCV infection, 51.3% had HIV coinfection, and 54.1% were HCV genotype 1.

• Superiority to the efficacy threshold was reported in the mFAS population (99.3%; 95% confidence interval [CI] [96.3 – 99.9]), with 1 subject experiencing relapse posttreatment. The SVR12 rate was lower in the FAS when compared with the historic comparative group, mostly due to missing SVR12 data in the FAs.

• No AE was associated with treatment discontinuation and no AEs of hepatic decompensation of failure were reported. Regarding AEs, 2 patients experienced serious AEs; however, they were not associated with G/P treatment.

• No participants experienced on-treatment ALT elevations of grade ≥2 which worsened from baseline. All incidences were comparable with the chronic HCV comparator cohort.

• During the treatment period, all patients with an ALT grade ≥2 at baseline improved to grade 0/1 according to the PSS (n =42/42) and FAS (n = 53/53).

• Among the 6 patients with a total bilirubin grade ≥2 at baseline, 5 improved to grade 0/1. The 1 patient with a grade 4 at baseline improved to grade 2 during the trial.

“These data support further clinical investigation of the 8-week G/P regimen in acute HCV, to enable shortening of the care cascade and reducing onward HCV transmission, and helping to achieve HCV elimination,” they concluded.

Reference: Pol S, Thompson A, Collins M, Venier E, et al. Effectiveness and Safety of 8-Week Glecaprevir/Pibrentasvir for the Treatment of Patients With Acute Hepatitis C: A Single-Arm Retrospective Study. Paper Presented at: AASLD The Liver Meeting, November 10-14, 2023. Accessed November 22, 2023.